Details for New Drug Application (NDA): 064097
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The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
Summary for 064097
Tradename: | DOXORUBICIN HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | doxorubicin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 064097
Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 064097
Suppliers and Packaging for NDA: 064097
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE;INJECTION | 064097 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9087 | 0143-9087-01 | 1 VIAL, MULTI-DOSE in 1 BOX (0143-9087-01) / 100 mL in 1 VIAL, MULTI-DOSE |
DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE;INJECTION | 064097 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9091 | 0143-9091-01 | 1 VIAL, MULTI-DOSE in 1 BOX (0143-9091-01) / 100 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/100ML | ||||
Approval Date: | Sep 13, 1994 | TE: | AP | RLD: | No |
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